Strategist / Senior Strategist - Regulatory Affairs
Core
Develops and executes regulatory strategies for pharmaceutical products across the UK, Ireland, Malta, Sweden, Finland, Norway, and Denmark, managing national and European procedures.
Role type
Senior Regulatory Affairs Strategist
Builds
Regulatory submissions, packaging materials, leaflets, SmPCs, and compliance databases for EMEA markets
Domain
Life Sciences / Pharmaceuticals
Required skills
Regulatory strategy, National and European procedures (Decentralized, Mutual Recognition), regulatory submissions, pharmacovigilance support, compliance management, database maintenance, SOP adherence
Preferred skills
CMC, Quality, or Regulatory Operations experience
Technologies
emc, medicines.ie, In-Demand
Responsibilities
Prepare and compile regulatory submissions and responses to questions; sign off on packaging materials, leaflets, and SmPCs; support Calls for Information (CFI) and Pharmacovigilance activities; ensure adherence to global, regional, and local databases and processes
Seniority
Senior, hands-on IC